Developing software based medical devices, including those using artificial intelligence (AI), requires quality controls.
If you develop the software, you are the manufacturer. A manufacturer must meet safety, quality, and performance requirements. You may also need to put in place a Quality Management System.
If your software is hosted or distributed across borders, it may be considered imported or exported under Australian law. For example, supply through cloud platforms or app stores. In this case, you'll have to meet our requirements for international supply.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.
Conformity assessment
Find conformity assessment requirements and variations.
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FormsInformation and templates for manufacturers making an Australian declaration of conformity.
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GuidanceGuidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
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GuidanceGuidance on how to interpret Essential Principle 13B and how it applies to your device.
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GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
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PageConformity Assessment, Essential Principles and consent to supply.
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PageGuidance and links to information on Conformity Assessment for medical devices.
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PageInformation about our regulatory approach for software based medical devices.
Certification
Access information on applying for or varying certification.
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GuidanceGuidance for notifying the TGA about substantial changes to, or transfers of, Conformity Assessment certificates.
Evidence
Access evidence requirements for manufacturing medical devices.
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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
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PageThis page outlines requirements for medical devices that use Artificial Intelligence (AI) and machine learning.
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PageA manufacturer evidence application must be submitted and accepted by the TGA before you can commence an application for any medical device.
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PageInformation about the types of Real World Evidence (RWE) relevant in the Australian, for sponsors and manufacturers.
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GuidanceGuidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation.